ZKR Orthopedics Performs First U.S. Patella Lift Procedure Initiating FDA Trial
SAN FRANCISCO, Sept. 24, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a leader in innovative orthopedic solutions, today announced the successful performance of the first U.S. patella LIFT procedure, initiating its FDA PELICAN trial.
The outpatient surgery was performed on September 19th by Dr. Dennis C. Crawford, Professor of Orthopedics, at Oregon Health and Science University (OHSU) in Portland OR.
"The procedure went very smoothly, took under 45 minutes and the patient was able to begin weight bearing and motion immediately," said Dr. Crawford. "This patient is a 41 year old woman who has been suffering for many years from painful arthritis behind her patella. This new procedure marks a significant advancement in orthopedic care."
ZKR Orthopedics is dedicated to pushing the boundaries of orthopedic solutions and enhancing patient outcomes. The Patella LIFT procedure offers a minimally invasive method to unload the patella and relieve pain without the complications associated with other treatments. Patients are allowed immediate range of motion and weight bearing allowing faster return to activities.
"This is an exciting moment," said CEO Jeffrey Halbrecht, MD. "Finally, patients with knee pain from patellofemoral arthritis and chondromalacia of the patella have a new treatment option that avoids more complex surgeries such as a tibial tubercle osteotomy or knee replacement.”
The ZKR Orthopedics Patella LIFT procedure is less invasive and less expensive than existing options, making the procedure attractive to ASC's and Payors.
ZKR received FDA approval in February 2024 for its IDE trial based on a successful European Pilot study performed by Dr. Konrad Slynarski in Warsaw Poland. That 2 year study on 18 patients demonstrated significant improvement in pain and function particularly stair climbing, squatting and walking. Patients were able to successfully resume sports after the ZKR implant including tennis, mountain biking, skiing and hiking.
The PELICAN study will evaluate patients with later stage cartilage degeneration and osteoarthritis of the patellofemoral joint. The study will compare the results of the ZKR Patella LIFT Implant performed at Centers in the United States to a control group consisting of tibial tubercle osteotomy procedures performed at various centers in Europe. The trial’s primary endpoints consist of patient-reported outcomes, safety measures, and radiographic confirmation. Pain, function, and speed of recovery will make up the secondary endpoints.
OHSU is the first of four sites that will be enrolling patients in the first phase of this trial. Other planned sites include The Ohio State University in Columbus, OH, Alta Orthopedics in Santa Barbara, CA and Horizon Clinical Research in San Diego, CA. Ultimately there will be a total of 10 investigational sites in the US and 10 in Europe.
For more information on ZKR Orthopedics' products and the ongoing trial, visit www.zkrorthopedics.com or email info@zkrorthopedics.com.
Jeff Halbrecht
+14152050496
jhalbrecht@zkrorthopedics.com
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